title: No advantage of a rotational continuation phase in acute lymphoblastic leukemia in childhood treated with a BFM back-bone therapy.
abstract: BACKGROUND
  Our aim was to compare two different schedules of maintenance in pediatric acute lymphoblastic leukemia (ALL) treated with a BFM-based therapy, in a randomized study: an Arm with 6-MP + MTX (with or without vincristine and dexamethasone pulses) versus a more intensive continuation phase.
  
  
  METHODS
  From January 1996 to November 2002, 429 eligible children with ALL were enrolled in a protocol with BFM-based back-bone, followed by a randomized continuation phase in standard (SRG) and intermediate (IRG) risk groups. Patients were randomized between Arms A and B for SRG and B or C for IRG. Arms A and C consisted of 6-MP and MTX and in Arm C, six pulses of VCR and dexamethasone were added. Arm B combined four pairs of drugs rotated weekly. All risk-groups received maintenance until completing 2 years of therapy from diagnosis.
  
  
  RESULTS
  With a median follow-up of 138 (range: 96-178) months, the overall pEFS (SE) was 72 (6)% for all patients and the different risk groups showed: SRG: 85 (3)%, IRG: 71 (1)%, and HRG: 42 (7)% (P-value ≤ 0.0001). The pDFS (SE) according to the assigned arm of maintenance was, for Arm A: 89 (3)% and for Arm B: 85 (4)% in SRG, and, for Arm B: 77 (4)% and for Arm C: 75 (4)% in IRG, at 10 years follow-up. There were no statistically significant differences in outcome between arms of maintenance for both risk groups.
  
  
  CONCLUSIONS
  In protocols with initial BFM-based strategy, a more intensive continuation phase did not benefit any risk group of patients.
authors.affiliation: Department of Hematology-Oncology, Hospital de Pediatría Prof. Dr. Juan P. Garrahan, Buenos Aires, Argentina. marisa_felice@yahoo.com.ar
authors.forename: Maria S
authors.initials: MS
authors.lastname: Felice
authors.forename: Jorge G
authors.initials: JG
authors.lastname: Rossi
authors.forename: Marta S
authors.initials: MS
authors.lastname: Gallego
authors.forename: Elizabeth M
authors.initials: EM
authors.lastname: Alfaro
authors.forename: Pedro A
authors.initials: PA
authors.lastname: Zubizarreta
authors.forename: Lidia E
authors.initials: LE
authors.lastname: Fraquelli
authors.forename: Cristina N
authors.initials: CN
authors.lastname: Alonso
authors.forename: Myriam R
authors.initials: MR
authors.lastname: Guitter
authors.forename: Marcelo J
authors.initials: MJ
authors.lastname: Scopinaro
mesh_terms: D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage*; D001215:Asparaginase / Q000008:administration & dosage; D002675:Child, Preschool; D003630:Daunorubicin / Q000008:administration & dosage; D018572:Disease-Free Survival; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007223:Infant; D008297:Male; D054198:Precursor Cell Lymphoblastic Leukemia-Lymphoma / Q000188:drug therapy* / Q000401:mortality; D011241:Prednisone / Q000008:administration & dosage; D012307:Risk Factors; D015996:Survival Rate; D014750:Vincristine / Q000008:administration & dosage
chemical_list: D014750:Vincristine; D001215:Asparaginase; D011241:Prednisone; D003630:Daunorubicin